[Congressional Record Volume 166, Number 195 (Tuesday, November 17, 2020)]
[House]
[Pages H5805-H5807]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 MAKING OBJECTIVE DRUG EVIDENCE REVISIONS FOR NEW LABELING ACT OF 2020

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5668) to amend the Federal Food, Drug, and Cosmetic Act to 
modernize the labeling of certain generic drugs, and for other 
purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5668

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Making Objective Drug 
     Evidence Revisions for New Labeling Act of 2020'' or the 
     ``MODERN Labeling Act of 2020''.

     SEC. 2. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by inserting after section 
     503C the following:

     ``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.

       ``(a) Definitions.--For purposes of this section:
       ``(1) The term `covered drug' means a drug approved under 
     section 505(c)--
       ``(A) for which there are no unexpired patents included in 
     the list under section 505(j)(7) and no unexpired period of 
     exclusivity;
       ``(B) for which the approval of the application has been 
     withdrawn for reasons other than safety or effectiveness; and
       ``(C) for which--
       ``(i)(I) there is new scientific evidence available 
     pertaining to the existing conditions of use that is not 
     reflected in the labeling;
       ``(II) the approved labeling does not reflect current legal 
     and regulatory requirements for content or format; or
       ``(III) there is a relevant accepted use in clinical 
     practice that is not reflected in the approved labeling; and
       ``(ii) updating the labeling would benefit the public 
     health.
       ``(2) The term `period of exclusivity', with respect to a 
     drug approved under section 505(c), means any period of 
     exclusivity under clause (ii), (iii), or (iv) of section 
     505(c)(3)(E), clause (ii), (iii), or (iv) of section 
     505(j)(5)(F), or section 505A, 505E, or 527.
       ``(3) The term `generic version' means a drug approved 
     under section 505(j) whose reference listed drug is a covered 
     drug.
       ``(4) The term `relevant accepted use' means a use for a 
     drug in clinical practice that is supported by scientific 
     evidence that appears to the Secretary to meet the standards 
     for approval under section 505.
       ``(5) The term `selected drug' means a covered drug for 
     which the Secretary has determined through the process under 
     subsection (c) that the labeling should be changed.
       ``(b) Identification of Covered Drugs.--The Secretary may 
     identify covered drugs for which labeling updates would 
     provide a public health benefit. To assist in identifying 
     covered drugs, the Secretary may do one or both of the 
     following:
       ``(1) Enter into cooperative agreements or contracts with 
     public or private entities to review the available scientific 
     evidence concerning such drugs.
       ``(2) Seek public input concerning such drugs, including 
     input on whether there is a relevant accepted use in clinical 
     practice that is not reflected in the approved labeling of 
     such drugs or whether new scientific evidence is available 
     regarding the conditions of use for such drug, by--
       ``(A) holding one or more public meetings;
       ``(B) opening a public docket for the submission of public 
     comments; or
       ``(C) other means, as the Secretary determines appropriate.
       ``(c) Selection of Drugs for Updating.--If the Secretary 
     determines, with respect to a covered drug, that the 
     available scientific evidence meets the standards under 
     section 505 for adding or modifying information to the 
     labeling or providing supplemental information to the 
     labeling regarding the use of the covered drug, the Secretary 
     may initiate the process under subsection (d).
       ``(d) Initiation of the Process of Updating.--If the 
     Secretary determines that labeling changes are appropriate 
     for a selected drug pursuant to subsection (c), the Secretary 
     shall provide notice to the holders of approved applications 
     for a generic version of such drug that--
       ``(1) summarizes the findings supporting the determination 
     of the Secretary that the available scientific evidence meets 
     the standards under section 505 for adding or modifying 
     information or providing supplemental information to the 
     labeling of the covered drug pursuant to subsection (c);
       ``(2) provides a clear statement regarding the additional, 
     modified, or supplemental information for such labeling, 
     according to the determination by the Secretary (including, 
     as applicable, modifications to add the relevant accepted use 
     to the labeling of the drug as an additional indication for 
     the drug); and
       ``(3) states whether the statement under paragraph (2) 
     applies to the selected drug as a class of covered drugs or 
     only to a specific drug product.
       ``(e) Response to Notification.--Within 30 days of receipt 
     of notification provided by the Secretary pursuant to 
     subsection (d), the holder of an approved application for a 
     generic version of the selected drug shall--
       ``(1) agree to change the approved labeling to reflect the 
     additional, modified, or supplemental information the 
     Secretary has determined to be appropriate; or
       ``(2) notify the Secretary that the holder of the approved 
     application does not believe that the requested labeling 
     changes are warranted and submit a statement detailing the 
     reasons why such changes are not warranted.
       ``(f) Review of Application Holder's Response.--
       ``(1) In general.--Upon receipt of the application holder's 
     response, the Secretary shall promptly review each statement 
     received under subsection (e)(2) and determine which labeling 
     changes pursuant to the Secretary's notice under subsection 
     (d) are appropriate, if any. If the Secretary disagrees with 
     the reasons why such labeling changes are not warranted, the 
     Secretary shall provide opportunity for discussions with the 
     application holders to reach agreement on whether the 
     labeling for the covered drug should be updated to reflect 
     available scientific evidence, and if so, the content of such 
     labeling changes.
       ``(2) Changes to labeling.--After considering all responses 
     from the holder of an approved application under paragraph 
     (1) or (2) of subsection (e), and any discussion under 
     paragraph (1), the Secretary may order such holder to make 
     the labeling changes the Secretary determines are 
     appropriate. Such holder of an approved application shall--
       ``(A) update its paper labeling for the drug at the next 
     printing of that labeling;
       ``(B) update any electronic labeling for the drug within 30 
     days of such order; and
       ``(C) submit the revised labeling through the form, 
     `Supplement--Changes Being Effected'.
       ``(g) Violation.--If the holder of an approved application 
     for the generic version of the selected drug does not comply 
     with the requirements of subsection (f)(2), such generic 
     version of the selected drug shall be deemed to be misbranded 
     under section 502.
       ``(h) Limitations; Generic Drugs.--
       ``(1) In general.--With respect to any labeling change 
     required under this section, the generic version shall be 
     deemed to have the same conditions of use and the same 
     labeling as its reference listed drug for purposes of clauses 
     (i) and (v) of section 505(j)(2)(A). Any labeling change so 
     required shall not have any legal effect for the applicant 
     that is different than the legal effect that would have 
     resulted if a supplemental application had been submitted and 
     approved to conform the labeling of the generic version to a 
     change in the labeling of the reference drug.
       ``(2) Supplemental applications.--Changes to labeling made 
     in accordance with this section shall not be eligible for an 
     exclusivity period under this Act.
       ``(3) Selection of drugs.--Nothing in this section shall be 
     construed to give the Secretary the authority to identify a 
     drug as a covered drug or select a drug label for updating 
     solely based on the availability of new safety information. 
     Upon identification of a drug as a covered drug, the 
     Secretary may then consider the availability of new, 
     additional, or different safety information in determining 
     whether the drug is a selected drug and in determining what 
     labeling changes are appropriate.
       ``(4) Maintenance of labeling.--Nothing in this section 
     shall be construed to affect the responsibility of the holder 
     of an approved application under section 505(j) to maintain 
     its labeling in accordance with existing requirements, 
     including subpart B of part 201 and sections 314.70 and 
     314.97 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(i) Rules of Construction.--
       ``(1) Approval standards.--This section shall not be 
     construed as altering the applicability of the standards for 
     approval of an application under section 505. No order shall 
     be issued under this subsection unless the scientific 
     evidence supporting the changed labeling meets the standards 
     for approval applicable to any change to labeling under 
     section 505.
       ``(2) Secretary authority.--Nothing in this section shall 
     be construed to limit the authority of the Secretary to 
     require labeling changes under section 505(o).
       ``(j) Reports.--Not later than 4 years after the date of 
     the enactment of the Making Objective Drug Evidence Revisions 
     for New Labeling Act of 2020, and every 4 years thereafter, 
     the Secretary shall prepare and submit to the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, a report that--

[[Page H5806]]

       ``(1) describes the actions of the Secretary under this 
     section, including--
       ``(A) the number of covered drugs and description of the 
     types of drugs the Secretary has selected for labeling 
     changes and the rationale for such recommended changes; and
       ``(B) the number of times the Secretary entered into 
     discussions concerning a disagreement with an application 
     holder or holders and a summary of the decision regarding a 
     labeling change, if any; and
       ``(2) includes any recommendations of the Secretary for 
     modifying the program under this section.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 5668.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 5668, the MODERN 
Labeling Act.
  Prescription drug labels contain the most authoritative drug-related 
information available to prescribers. These labels let prescribers know 
about approved uses for a drug and important patient safety 
information.
  However, over time, labels can become outdated as more information 
becomes known about a drug, but a manufacturer may not update the label 
with the Food and Drug Administration to identify new uses for drugs. 
This is especially likely to happen with some older generic drugs where 
there may be commonly accepted off-label uses but no FDA-sanctioned 
method of communicating those safe uses.
  In some cases, a generic drug may have an outdated label due to a 
loophole in the law. Under this loophole, if a listed brand drug leaves 
the market while a generic competitor remains, there is no way for the 
generic drug to update its label with approved new uses. This is 
because generic drugs must maintain the same drug information on their 
labels as their branded counterparts, even when their branded 
counterpart has left the market.
  This bipartisan legislation, Mr. Speaker, would fix this problem. 
H.R. 5668 would allow FDA to identify drugs that have out-of-date 
labels and pursue revised labeling, allowing new uses and new 
indications to be listed. This will allow FDA and generic drug 
manufacturers to ensure that drug labels, the most trusted source of 
drug use information, include the best information available.
  Mr. Speaker, it is important to note that both brand and generic 
manufacturers have the responsibility to work with FDA to update drug 
safety information that becomes known and that does not change under 
this bill.
  Amendments adopted through our committee process ensure that, when a 
manufacturer needs to update a label solely with new safety 
information, manufacturers and FDA must pursue such changes through the 
current process. Drug safety is paramount, and we want patients to have 
certainty that they will have up-to-date safety information.
  As Dr. Jeff Allen from the Friends of Cancer Research said at our 
hearing on this bill: ``Preserving the accuracy and reliability of 
labeling may be viewed as tantamount to preserving trust in and the 
relevance of the drug approval system.''
  And I cannot agree more, Mr. Speaker. Maintaining our trust in the 
FDA approval process is critical, and this bill will help strengthen 
the system.
  Mr. Speaker, I urge all Members to support this bill, and I reserve 
the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 5668. This is the MODERN 
Labeling Act, and I want to thank our colleagues, Representatives 
Guthrie and Matsui, for their leadership on this important legislation 
which will allow the FDA to require modifications be made to outdated 
labeling for generic drugs.
  Now, while drug manufacturers are required to update a label when it 
becomes inaccurate, false, or misleading, there is no such requirement 
when new scientific information indicates there may be a new use for 
the product.
  Generic drugs are generally required to have the same labeling as the 
brand drug they reference; however, once the brand drug is no longer on 
the market, the generic manufacturer is actually prohibited from 
updating their label to reflect the most accurate, up-to-date 
information, information that is often discovered through postmarket 
use. So the inability to update labeling can result in information gaps 
for providers and patients when discussing treatments.
  For example, it has been estimated that more than half, Mr. Speaker--
half--of all uses of cancer drugs are off-label, meaning the drug is 
used for a disease or medical condition that it is not approved to 
treat. Many of these uses are widely accepted in the medical community 
and based on the most up-to-date scientific evidence; however, they are 
not reflected in FDA-approved labeling.

  So H.R. 5668 would help. It would close this existing information 
gap. It would give doctors and patients the information they need when 
making decisions about their treatment options.
  Mr. Speaker, I urge support of this bill, and I reserve the balance 
of my time.
  Mr. PALLONE. Mr. Speaker, I believe we have a speaker on the other 
side, so I continue to reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield 3 minutes to the gentleman from 
Kentucky (Mr. Guthrie), one of our terrific leaders on the Energy and 
Commerce Committee on the Republican side and someone who put a lot of 
time and effort into this bipartisan legislation.
  Mr. GUTHRIE. Mr. Speaker, I thank the ranking member for yielding.
  I appreciate working with the chairman and with everyone involved in 
this piece of legislation.
  I rise today to voice my support for H.R. 5668, the MODERN Labeling 
Act of 2020. This important bill will ensure that certain drug labels 
are updated and accurate, which will result in better care for many 
Americans who are suffering. This bill grants FDA the authority to work 
with generic drug companies to update their product label when there 
are strong, scientific bases for another indication or use of the drug.
  Innovation in America is constantly evolving, and we must ensure drug 
labels are updated and not frozen in time just because the brand-name 
drug is off the market and preventing the generic drug from updating 
its label.
  I would like to thank Representative Matsui, Chairman Pallone, and 
the majority and minority Energy and Commerce Committee staff who 
worked with me to make this legislation possible.
  I urge my colleagues to support this important bill.
  Mr. PALLONE. Mr. Speaker, may I inquire if the gentleman has any 
additional speakers.
  Mr. WALDEN. Mr. Speaker, no, I do not.
  I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I ask all of our Members to support this 
bill, and I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 5668, the MODERN 
Labeling Act. I'm proud to have advanced this bipartisan bill through 
my Health Subcommittee and I'm proud to support it on the Floor today.
  The MODERN Labeling Act was introduced by Representatives Doris 
Matsui and Bret Guthrie, and allows generic drug companies to update 
outdated labeling
  Drug labeling can become outdated when new scientific evidence is 
discovered after a drug is on the market, yet drug manufacturers are 
not required by law to update their products' labeling with new uses.
  Because of this system, the labeling of many cancer drugs, especially 
older generic products, are out of date. Outdated labeling can affect 
insurance and Medicare coverage of the drugs, creating potentially high 
out-of-pocket costs for consumers.
  H.R. 5668 addresses this problem by giving the FDA the authority to 
require labels to reflect new information relevant to the drug and its 
use.
  This is a commonsense bill that will help more cancer patients have 
access to the treatments they need and I urge all my colleagues to 
support this legislation.

[[Page H5807]]

  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 5668, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________